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Analgesic Effect of Preoperative Dexamethasone in Gynecological Laparotomies - a Dose-ranging Study

Primary Purpose

Postoperative Pain, Postoperative Nausea and Vomiting, Fatigue

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Dexamethasone (0.1 mg/kg)
Dexamethasone (0.2 mg/kg)
Saline
Sponsored by
Women's College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Elective total abdominal hysterectomy (with or without salpingo-oophorectomy or minor bladder repair) or myomectomy, through a lower transverse or low midline incision under general anesthesia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients must be non-lactating
  • 18-65 years of age
  • ASA groups I-III for elective total abdominal hysterectomy (with or without salpingo-oophorectomy or minor bladder repair)or myomectomy through a lower transverse or low midline incision under general anesthesia. Incidental appendectomy and /or abdominal lipectomy were allowed as collateral surgical procedures if the same incision was used

Exclusion Criteria:

  • Emergent procedures
  • Diagnosed malignancy
  • History of allergy to dexamethasone
  • Allergy or contraindication to drugs used in study and anesthesia
  • Patients with uncontrolled diabetes mellitus, recent history of gastrointestinal bleeding or ulceration within 30 days before the study)
  • Patients who have taken drugs in the 12 hours preceding the surgery that could confound the analgesic response (specifically analgesics, neuroleptics, corticosteroids, NSAIDs)
  • Patients who have been on long term oral steroid therapy
  • Patients with BMI>40
  • Serious organ disease/ dysfunction
  • Chronic pain patients requiring >30mg morphine per day or equivalent
  • Severe psychiatric disease
  • Drug Addiction
  • Pregnancy
  • Language barrier
  • Inability to cooperate with the use of the intravenous PCA morphine pump

Sites / Locations

  • Women's College Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dexamethasone

Saline

Arm Description

Outcomes

Primary Outcome Measures

Total cumulative morphine consumption via the patient-controlled analgesia (PCA) pump in the first 24 hours

Secondary Outcome Measures

Total cumulative postoperative morphine consumption after 48 hours
Numerical Rating Scale at rest (supine) and on movement (on sitting) at baseline, 1, 6, 12, 24 and 48 hours after surgery
Total fentanyl administration intraoperatively and in the PACU
Time to first analgesic request in the PACU
Time to discharge from the PACU

Full Information

First Posted
November 27, 2009
Last Updated
October 15, 2013
Sponsor
Women's College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01022528
Brief Title
Analgesic Effect of Preoperative Dexamethasone in Gynecological Laparotomies - a Dose-ranging Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Women's College Hospital

4. Oversight

5. Study Description

Brief Summary
The objective of the study is to examine the effect of the addition of intravenous dexamethasone 1.5 hours prior to induction of anesthesia on the post-operative opioid consumption, pain scores, fatigue, and recovery in patients undergoing gynecological surgery with laparotomy under general anesthesia. This is a dose finding study with two different doses (0.1 mg/kg vs. 0.2 mg/kg) of dexamethasone to find out the optimal efficacious dose of dexamethasone with minimal side effects. Dexamethasone has anti-inflammatory, immunomodulatory, and analgesic effects; and is superior to placebo in providing post-operative pain control, lower analgesic consumption, prevention of postoperative nausea and vomiting, lesser post-operative fatigue, and better recovery profile. No dose response study has been done. The investigators hypothesize that a higher dose of dexamethasone may have an incremental beneficial effect.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Postoperative Nausea and Vomiting, Fatigue
Keywords
Elective total abdominal hysterectomy (with or without salpingo-oophorectomy or minor bladder repair) or myomectomy, through a lower transverse or low midline incision under general anesthesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
138 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexamethasone
Arm Type
Experimental
Arm Title
Saline
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Dexamethasone (0.1 mg/kg)
Other Intervention Name(s)
Dose = 0.1 mg/kg
Intervention Type
Drug
Intervention Name(s)
Dexamethasone (0.2 mg/kg)
Other Intervention Name(s)
Dose = 0.2 mg/kg
Intervention Type
Other
Intervention Name(s)
Saline
Primary Outcome Measure Information:
Title
Total cumulative morphine consumption via the patient-controlled analgesia (PCA) pump in the first 24 hours
Secondary Outcome Measure Information:
Title
Total cumulative postoperative morphine consumption after 48 hours
Title
Numerical Rating Scale at rest (supine) and on movement (on sitting) at baseline, 1, 6, 12, 24 and 48 hours after surgery
Title
Total fentanyl administration intraoperatively and in the PACU
Title
Time to first analgesic request in the PACU
Title
Time to discharge from the PACU

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must be non-lactating 18-65 years of age ASA groups I-III for elective total abdominal hysterectomy (with or without salpingo-oophorectomy or minor bladder repair)or myomectomy through a lower transverse or low midline incision under general anesthesia. Incidental appendectomy and /or abdominal lipectomy were allowed as collateral surgical procedures if the same incision was used Exclusion Criteria: Emergent procedures Diagnosed malignancy History of allergy to dexamethasone Allergy or contraindication to drugs used in study and anesthesia Patients with uncontrolled diabetes mellitus, recent history of gastrointestinal bleeding or ulceration within 30 days before the study) Patients who have taken drugs in the 12 hours preceding the surgery that could confound the analgesic response (specifically analgesics, neuroleptics, corticosteroids, NSAIDs) Patients who have been on long term oral steroid therapy Patients with BMI>40 Serious organ disease/ dysfunction Chronic pain patients requiring >30mg morphine per day or equivalent Severe psychiatric disease Drug Addiction Pregnancy Language barrier Inability to cooperate with the use of the intravenous PCA morphine pump
Facility Information:
Facility Name
Women's College Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 1B2
Country
Canada

12. IPD Sharing Statement

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Analgesic Effect of Preoperative Dexamethasone in Gynecological Laparotomies - a Dose-ranging Study

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